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Generated: December 13, 2018

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CLINICAL TRIALS PROFILE FOR HYLENEX RECOMBINANT

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Clinical Trials for Hylenex Recombinant

Trial ID Title Status Sponsor Phase Summary
NCT00311519 A Phase IIIB Dose Comparison Study of Subcutaneous Hydration With and Without Human Recombinant Hyaluronidase (HYLENEX) in Volunteer Subjects Completed Halozyme Therapeutics Phase 4 The purpose of this research study to test the effectiveness of a study medication to increase how fast a solution called lactated Ringer’s is absorbed when put under the skin subcutaneously. The medication to be studied is an enzyme called hyaluronidase, and is a human recombinant form of the enzyme. The drug company name for this medication is Hylenex. Hylenex was currently an investigational medication at the initiation of the study, but received FDA approval during the study. An investigational medication is a medication or formulation of a medication that is not approved by the United States Food and Drug Administration for use in this country but may be used in studies such as this one.
NCT00435604 A Study of the Subcutaneous Injection of a Viscous Antibody Solution With Recombinant Human Hyaluronidase Completed Halozyme Therapeutics Phase 1 This Phase I, randomized, double-blinded, within-subject controlled, two-way crossover study comparing the time to inject (flow rate), safety, and tolerability of a subcutaneously (SC) administered, viscous antibody solution of with and without human recombinant hyaluronidase (rHuPH20) in volunteer subjects. The study hypothesizes that the time required to complete a 20-mL SC injection of a viscous antibody with rHuPH20 will be comparable or shorter than the time required for the injection without rHuPH20.
NCT00477152 Study of Subcutaneous Rehydration With Recombinant Human Hyaluronidase for Infants and Children Completed Halozyme Therapeutics Phase 4 The aim of the study is to evaluate the safety, effectiveness and ease of use of subcutaneous (SC) rehydration using HYLENEX-augmented SC infusion of fluids and electrolytes for the rehydration of pediatric patients with mild to moderate dehydration.
NCT00477152 Study of Subcutaneous Rehydration With Recombinant Human Hyaluronidase for Infants and Children Completed PPD Phase 4 The aim of the study is to evaluate the safety, effectiveness and ease of use of subcutaneous (SC) rehydration using HYLENEX-augmented SC infusion of fluids and electrolytes for the rehydration of pediatric patients with mild to moderate dehydration.
NCT00477152 Study of Subcutaneous Rehydration With Recombinant Human Hyaluronidase for Infants and Children Completed Baxter Healthcare Corporation Phase 4 The aim of the study is to evaluate the safety, effectiveness and ease of use of subcutaneous (SC) rehydration using HYLENEX-augmented SC infusion of fluids and electrolytes for the rehydration of pediatric patients with mild to moderate dehydration.
NCT00493220 Pharmacokinetic and Safety Study of HYLENEX Recombinant-Augmented Subcutaneous Ceftriaxone Administration Completed Halozyme Therapeutics Phase 1 The objectives of this study are: - to establish the safety of subcutaneous administration of ceftriaxone at different concentrations, with and without HYLENEX recombinant, and to determine the maximum tolerated concentration; - and to establish the pharmacokinetic comparability of subcutaneous administration of ceftriaxone with HYLENEX recombinant to subcutaneous administration without HYLENEX recombinant and to IV administration.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Hylenex Recombinant

Condition Name

Condition Name for Hylenex Recombinant
Intervention Trials
Dehydration 8
Healthy 6
Type 1 Diabetes Mellitus 5
Diabetes Mellitus, Type 1 2
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Condition MeSH

Condition MeSH for Hylenex Recombinant
Intervention Trials
Diabetes Mellitus 11
Dehydration 8
Diabetes Mellitus, Type 1 7
Diabetes Mellitus, Type 2 2
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Clinical Trial Locations for Hylenex Recombinant

Trials by Country

Trials by Country for Hylenex Recombinant
Location Trials
United States 90
Kenya 1
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Trials by US State

Trials by US State for Hylenex Recombinant
Location Trials
California 13
Texas 7
Michigan 6
Florida 6
Washington 4
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Clinical Trial Progress for Hylenex Recombinant

Clinical Trial Phase

Clinical Trial Phase for Hylenex Recombinant
Clinical Trial Phase Trials
Phase 4 10
Phase 3 1
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Hylenex Recombinant
Clinical Trial Phase Trials
Completed 22
Unknown status 2
Not yet recruiting 2
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Clinical Trial Sponsors for Hylenex Recombinant

Sponsor Name

Sponsor Name for Hylenex Recombinant
Sponsor Trials
Halozyme Therapeutics 22
Baxter Healthcare Corporation 10
Massachusetts General Hospital 2
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Sponsor Type

Sponsor Type for Hylenex Recombinant
Sponsor Trials
Industry 33
Other 9
NIH 1
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